As requested, the potential health hazard of the presence of arsenic (As) in pear juice products was considered.

Estimates of fruit juice consumption were derived from results of the two most recent national food consumption surveys: the 1994-98 Continuing Survey of Food Intakes by Individuals (CSFII) and the 2003-04 National Health and Nutrition Examination Survey (NHANES). Although the NHANES is more recent, consumption estimates from the CSFII were also considered because of the larger sample size. Both surveys included two days of consumption records for most survey participants.

Although the issue at hand is dietary exposure to arsenic from pear juice/concentrate, information on pear juice consumption was limited in both the CSFII and the NHANES. Only two food codes were reported for pear juice (infant/toddler pear juice and pear nectar) and the number of consumers of either product was too few to allow the calculation of upper percentiles of consumption. As an alternate approach, consumption estimates taking into account consumption of all fruit juices were used as a surrogate for consumption of pear juice.

Consumption estimates were based on average consumption over two days for individuals who consumed juice (eaters only) and were calculated for two population groups: Males and females (MF) from birth to 2 years of age and MF 2 years of age and older. The consumption estimates are summarized in Table 1.

Since consumption estimates from both surveys are similar (Table 1), results from the more recent 2003-04 NHANES were used to calculate levels of concern (LOC). Based on the estimated consumption of all fruit juices (2003-04 NHANES database) and the established safe/tolerable levels of exposure to inorganic arsenic for short-term exposure (the provisional minimal risk level, MRL, of 0.005 mg/kg body weight/day) by CDC/ATSDR and for chronic exposure (Reference dose, RfD), of 3 x 10-4 mg/kg body weight/day) by EPA, the levels of concern of inorganic arsenic in fruit juices are presented in Table 2.

As shown in Table 2, for short-term exposure, arsenic concentrations in fruit juices at 262 and 115µg/kg are the LOCs for the average and the 90th percentile consumers, respectively, for MF birth to 2 years of age. For chronic exposure, using the consumption surrogate for MF 2 years of age and older, inorganic arsenic levels below 50 and 23 µg/kg in fruit juices would not pose a health concern for the mean and the 90th percentile juice consumers, respectively. These levels are in good agreement with the EPA drinking water and FDA bottled water standards of inorganic arsenic of 10 µg/L. Even though arsenic concentrations are 5 and 2.3 times higher, respectively, for average and 90th percentile consumers, juice consumption levels (221 and 449 ml/day, respectively) are correspondingly lower than drinking water intake (1-2L/day).

The Total Diet Study (TDS) is an ongoing program that involves the collection and analysis of about 280 different foods four times each year. For each sample collection (or market basket), three samples of each TDS food are collected in three different cities within the region; the three samples are composited prior to analysis. Each TDS food composite is analyzed for about 300 different analytes, including toxic elements (total arsenic, cadmium, lead, and total mercury). Among the foods sampled in the TDS are various fruits juices, including two baby food juices. Electronic records of TDS analytical results are available from the third market basket of 1991 (MB 91-3) through the fourth market basket of 2005 (MB 05-4). Most fruit juices were sampled in 51 market baskets between 1991 and 2005; three juices were added to the TDS in 2003 and were sampled 12 times between 2003 and 2005.

Results for total arsenic levels in TDS samples of fruit juices are summarized in Table 3. The Level of Detection (LOD) for arsenic in fruit juices is 0.008 mg/kg. Overall, only 12% of fruit juice samples had detectable levels of arsenic. Mean arsenic levels, assuming a value of zero for samples below the LOD, ranged from 0 to 13 µg/kg. Only 4 juice samples had total arsenic levels (24, 25, 29 and 44 µg/kg) above the Level of Concern (LOC) of 23 µg/kg for chronic exposure. This represents 0.9% (=4/443) of the total samples or 7% (=4/55) of the samples with detected arsenic levels.

In addition to the TDS samples collected in the TDS, FDA also collected samples of pear juice products in March 2008. Total arsenic levels found in these pear juice samples are shown in Table 4. There are a total of 9 samples of finished juice (as consumed) and 12 samples of juice concentrate/blend. In the finished juice samples, total arsenic levels range from non-detected to 66 µg/kg. In the pear juice concentrate/blend samples, total arsenic levels when calculated on a finished-juice basis range from 6.5 to 87.9 µg/kg. Since chemical forms of arsenic in these pear juice products are not available, we assumed that all arsenic is inorganic arsenic. Of the 9 finished pear juice product samples, 6 (67%) had total arsenic levels above the chronic LOC. Of the 12 samples of pear concentrate/blend, 9 (75%) had values as calculated on a finished-juice basis that exceeded the chronic LOC. None of samples had levels that exceeded the short-term LOC.

*Level of Concern (LOC) is calculated by dividing the selected safe exposure level of arsenic by the estimated juice consumption (NHANES database). aFor MF from birth to 2 years of age, MRL of 0.005 mg/kg bw/d for short-term exposure is used. bFor MF 2 years of age and older, RfD of 3 x 10-4 mg/kg bw/day for chronic exposure is used.